“Guidance for Industry and FDA Staff 510(k) Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems”. was issued Dec 28, 2004. This document mentions software in several places. The document at the link provided is highlighted in yellow to indicate each reference to software. The guidance.
This document states explicitly that it considers software used in such devices is moderate level of concern. It states that software lifecycle documentation appropriate for this level of concern, as indicated in its premarket submission and OTSS software guidances, should be provided to FDA in the 510(k).
This guidance lists 4 risks/hazards that are the minimum to address for this device including “ineffective treatment”.
This guidance also recommends conformance with IEC 60601-1-2 and/or IEC 61326 for EMC and one or more of IEC 60601-1, IEC 61010-1, UL 60601-1, and ANSI/AAMI ES-1 for electrical equipment safety.